The National Human Genome Research Institute (NHGRI) intends to publish a Funding Opportunity Announcement (FOA) to solicit for a consortium of collaborative genomic medicine pilot demonstration projects, designed to demonstrate the feasibility of, and develop methods for, incorporating an individual patient’s genomic findings into their clinical care.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in Summer, 2012, with an expected receipt date in Fall, 2012.

This FOA will utilize the U01 activity code. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into this area of assessing the feasibility of, and developing methods for, incorporating an individual patient’s genomic findings into their clinical care, to begin to consider applying for this new FOA.

The goals of this initiative are to expand existing genomic medicine efforts, and develop new collaborative projects and methods, in diverse settings and populations; contribute to the evidence base regarding outcomes of incorporating genomic information into clinical care; and define and disseminate the processes of genomic medicine implementation, diffusion, and sustainability in diverse clinical settings.

For the purposes of this initiative,is to incorporate an individual patient's genomic information (as reflected by their own genotypic, sequencing, family history, etc., data) into decision-making about their clinical care.

Among the areas of research encouraged in this initiative are screening for highly penetrant germline mutations to identify genetically at-risk individuals, integrating patient-reported family history information into the electronic medical record (EMR), and providing appropriate clinical decision support (CDS) for these efforts. Research designed to apply pharmacogenomic information in drug selection and dosing, and to use an individual patient's whole exome or genome sequence data for diagnosis or treatment, is also encouraged to the extent that proposed studies do not overlap with the current substantial NHGRI and NIH investments in these areas. It should be noted the areas listed above are only examples; innovative approaches for demonstrating the feasibility, and assessing the effects, of incorporating a patient's genomic findings in their clinical care are encouraged within the constraints of programmatic balance.